Medical Device Manufacturer · US , Mchenry , IL

Innotron of Oregon, Inc.

28 submissions · 28 cleared · Since 1980
28
Total
28
Cleared
0
Denied

Innotron of Oregon, Inc. — FDA 510(k) Submissions

Innotron of Oregon, Inc. has submitted 28 FDA 510(k) premarket notifications since 1980, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrators, Drug Specific, Fluorescence Polarization Immunoassay, Tobramycin, Fluorescence Polarization Immunoassay, Diphenylhydantoin (total), Radioimmunoassay, Vancomycin, Enzyme Immunoassay, Quinidine . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
INNOFLUOR (TM) AMIKACIN CALIBRATOR SET
K903101 · DLJ Calibrators, Drug Specific · Toxicology
Aug 1990 40d
INNOFLUOR (TM) AMIKACIN REAGENT SET
K903100 · KLQ Radioimmunoassay, Amikacin · Toxicology
Aug 1990 27d
MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR
K900707 · LFW Fluorescence Polarization... · Toxicology
Apr 1990 67d
MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
K900708 · LEH Radioimmunoassay, Vancomycin · Toxicology
Apr 1990 66d
MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
K900702 · LGI Fluorescence Polarization... · Toxicology
Apr 1990 59d
MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR
K900703 · LCD Enzyme Immunoassay,... · Toxicology
Apr 1990 59d
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
K900704 · LGQ Fluorescence Polarization... · Toxicology
Apr 1990 59d
MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR
K900705 · LBZ Enzyme Immunoassay,... · Toxicology
Apr 1990 59d
MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA
K900706 · LGS Fluorescence Polarization... · Toxicology
Apr 1990 59d
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
K895827 · LGR Fluorescence Polarization... · Toxicology
Oct 1989 29d
INNOFLUOR DIGOXIN CALIBRATOR SET
K895826 · DLJ Calibrators, Drug Specific · Toxicology
Oct 1989 28d
INNOFLUOR DIGOXIN REAGENT SET
K895828 · LCS Radioimmunoassay, Digoxin... · Toxicology
Oct 1989 28d
INNOFLUOR CARBAMAZEPINE CALIBRATOR SET
K893506 · DLJ Calibrators, Drug Specific · Chemistry
Aug 1989 102d
INNOFLUOR CARBAMAZEPINE REAGENT SET
K893507 · KLT Enzyme Immunoassay,... · Chemistry
Aug 1989 98d
INNOFLUOR(TM) QUINIDINE REAGENT SET
K892208 · LBZ Enzyme Immunoassay,... · Toxicology
Jun 1989 67d
INNOFLUOR(TM) QUINDINE CALIBATOR SET
K892212 · DLJ Calibrators, Drug Specific · Toxicology
Jun 1989 67d
INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
K872563 · LGR Fluorescence Polarization... · Chemistry
Aug 1987 58d
INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET
K872562 · LFW Fluorescence Polarization... · Chemistry
Aug 1987 54d
INNOFLUOR VANCOMYCIN REAGENT SET
K872579 · LEH Radioimmunoassay, Vancomycin · Chemistry
Aug 1987 48d
INNOFLUOR PHENYTOIN CALIBRATOR SET
K872142 · DLJ Calibrators, Drug Specific · Chemistry
Jul 1987 48d
INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET
K872349 · DLJ Calibrators, Drug Specific · Chemistry
Jul 1987 48d
INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET
K872461 · DLJ Calibrators, Drug Specific · Toxicology
Jul 1987 27d
INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET
K872462 · DLJ Calibrators, Drug Specific · Toxicology
Jul 1987 29d
INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET
K872463 · DLJ Calibrators, Drug Specific · Toxicology
Jul 1987 27d
INNOFLUOR VANCOMYCIN CALIBRATOR SET
K872644 · DLJ Calibrators, Drug Specific · Toxicology
Jul 1987 15d
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